S-LINE 8680205Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207042939), received between May 17, 2018 and Apr 8, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Material Twisted/Bent

  THE CUSTOMER STATED THAT THE HANDLE ON THE WORKPIECE IS BENT, PREVENTING THE HF LOOP FROM BEING MOVED ALL THE WAY TO THE END. THE SURGERY COULD NOT BE COMPLETED. THE USER DID NOT PROVIDE ANY INFORMATION REGARDING THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24821595 ↗
• InjuryApr 8, 2026Material Twisted/Bent

  THE CUSTOMER STATED THAT THE HANDLE ON THE WORK PIECE IS BENT, PREVENTING THE HF LOOP FROM BEING MOVED ALL THE WAY TO THE END. THE SURGERY COULD NOT BE COMPLETED. THE USER DID NOT PROVIDE ANY INFORMATION REGARDING THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24821580 ↗
• DeathSep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 11, 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: A PATIENT DEATH WAS REPORTED BY THE HOSPITAL (B)(6) IN (B)(6) WHERE AN S-LINE RESECTOSCOPE WORKING ELEMENT AND ACCESSORIES WERE BEING USED DURING A PROCEDURE, TRANSURETHRAL RESECTION OF THE BLADDER. THE BLADDER OF THE PATIENT WAS REPORTED TO HAVE BEEN FILLED WITH SODIUM CHLORIDE (NACL) SOLUTION. DURING THE RESECTION (NOT IN THE IGNITION PHASE), THE BLADDER BURST AND CAUSED A PELVIC ARTERY TO TEAR. THIS HAPPENED ALMOST AT THE END OF THE SURGICAL PROCEDURE. AN UNSUCCESSFUL EMERGENCY OPERATION WAS CARRIED OUT FOR OVER APPROXIMATELY THREE(3) HOURS, WITH FOUR (4) DOCTORS PRESENT. THE PATIENT EXPIRED DURING THE EMERGENCY OPERATION. THE PATIENT WAS (B)(6) YEARS OLD AND WAS IN NORMAL, GOOD STATE OF HEALTH. THERE WAS NO INFORMATION AVAILABLE REGARDING THE QUANTITY OF NACL USED OR ABOUT THE FLUSHING PRESSURE. THE POSITION OF THE NACL BOTTLE WAS APPROXIMATELY 1M ABOVE THE OPERATING TABLE WITHOUT A PUMP. IT IS CURRENTLY NOT KNOWN HOW LONG THE RESECTION TOOK.

  Patient problems: Death

  MAUDE report 9050559 ↗
• InjuryFeb 22, 2019Temperature Problem; Temperature Problem

  ON NOVEMBER 07, 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM RICHARD WOLF (B)(4) INVOLVING THE FOLLOWING DEVICES: 815.052 LOT 523/573 (MDR 9611102-2018-00015), 815.032 LOT 006/086 (MDR 9611102-2018-00016), 8674.205 LOT 1259038 (MDR 9611102-2018-00017), 8680.205 LOT 1255367 (THIS MDR), 8654.204 LOT 1202777 (MDR 9611102-2018-00019). IT WAS REPORTED THAT THE PATIENT SUFFERED THIRD DEGREE BURN ON THE RIGHT FINGER DUE TO HF APPLICATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSPECTION SHOWED THAT THE CAUSE OF THE FAULT DESCRIBED BY THE USER CANNOT BE TRACED BACK TO THE WORKING ELEMENTS OR HF CONNECTION CABLE MONO. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. NO DEFECTS WERE FOUND IN THE MEDICAL DEVICES. IN CONCLUSION, THE COMBUSTION WAS NOT CAUSED BY A FAULTY HF DEVICE OR ACCESSORY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8363751 ↗
• MalfunctionMay 17, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING BIPOLAR CUTTING AND COAGULATION DURING A BIPOLAR TUR, THE ANESTHESIOLOGIC SISTER JUST BELOW THE PUNCTURE SITE OF THE VENOUS CATHETER ON THE PATIENT'S LEFT FOREARM BURNED HER FINGERTIP OF THE RING FINGER TO THE RIGHT. ABOUT THIS CATHETER WAS ADMINISTERED A SALINE INFUSION. THE JUMPERS DURING THE PROCEDURE FOUND ONLY A CURRENT DELIVERY AT THE DESCRIBED LOCATION OF THE PATIENT. LEFT ARM OF THE PATIENT, PARALLEL TO RESECTION OF THE LEFT PROSTATE VALVE. IN OTHER PARTS OF THE PATIENT'S BODY NO CURRENT DELIVERY WAS DETECTED. TYPE: 8680.205 WORKING ELEMENT ACTIVE BIPO 0/12/30, MANUFACTURED DATE: 15 DEC 2015, LOT SIZE: (B)(4) UNITS, PURCHASE DATE: 19 DEC 2016.

  Patient problems: Burn(s); Electrocution

  MAUDE report 7522540 ↗